Ethicon, Inc. received FDA approval for the VISTASEAL Dual Applicator on April 10, 2019.
VISTASEAL is a single-use coagulant device that uses a combination of human fibrinogen and human thrombin to assist with mild to moderate intraoperative bleeding control when standard surgical techniques such as suture or cautery are ineffective. The sealant is applied in a thin layer over the bleeding tissue in order to generate a cross-linked fibrin clot to achieve hemostasis. VISTASEAL can be utilized in high-risk patients when there are concerns regarding coagulopathy, antiplatelets, anticoagulants, and friable tissue.
There are a variety of applicators that exist for utilization in both the open and laparoscopic setting. The human fibrin sealant comes in prefilled packaging that allows for easy set-up, and does not require mixing. The dual applicator mixes the fibrinogen and thrombin as the plunger is depressed. It is shipped and stored frozen, and has a shelf life of up to 2 years. VISTASEAL typically requires 5 minutes of thawing time in a sterile water bath (37°C) and is then ready for immediate use. The product boasts a broader range of working temperature (2°C-37°C) that allows for improved flexibility in the OR. It also utilizes an airless system that allows for both drip and spray applications. The product does not require the use of pressurized carbon dioxide external spray equipment for application.
Biocompatibility of the materials for the VISTASEAL Dual Applicator device was assessed and there were no biocompatibility risks associated with the materials selected. Hemocompatibility tests were also performed as some of the device components have direct contact with the Fibrin Sealant. These tests demonstrated that device materials are similar to the predicate device and are clinically acceptable for the delivery of the Fibrin Sealant.
The FDA determined this device is substantially equivalent to the EVICEL Airless Spray Accessory and EVICEL 6 cm Tip through its spray and drip application of Fibrin Sealant.
VISTASEAL is approved for treating mild to moderate intraoperative bleeding that cannot be controlled by standard surgical techniques. It is effective for use in heparinized patients
VISTASEAL should not be directly injected into the circulatory system due to a risk of thromboembolic events. It is not recommended for brisk or severe arterial bleeding. Its use should be avoided in patients with a history of severe systemic allergic reactions or anaphylaxis to human blood products.
